FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Clinical Packaging RFPs Made Easy
    Clinical Packaging RFPs Made Easy

    Managing clinical supplies is hard. Not hard like string theory — more like organizing a family vacation with your adult siblings and all their children. Clinical supplies management sits at the intersection of multiple disciplines, each with its unique perspectives and priorities. Their collective attention may be difficult to hold for something as seemingly trivial as packaging. However, clinical packaging is critical to the success of a program and a company, and an effective request for proposal (RFP) will guide you to the right packaging partner for your journey to product approval.

  • Should You Rotate Disinfectants? Industry Experts Weigh In
    Should You Rotate Disinfectants? Industry Experts Weigh In

    Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.

  • Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?
    Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products

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PHARMA OUTSOURCING WHITE PAPERS

Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.

Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production

Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

Accelerate Flavivirus Vaccine Production With Modern Bioprocess Tools And Solutions

This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.

9 Reasons To Consider A Single-Use Fermentor

Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets

Scale-Up Of A Cell-Based Influenza Virus Production Process

The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.

Four Reasons For The Rise In Blister Packaging

Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Pharmaceutical Development For ADCs: Not As Simple As ABC

Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. 

Partnering With The Right CRO To Complement Clinical Trial Analytics

Clinical development is the most costly aspect of getting drug, medical device or diagnostic to market. Previously priced at $1.3 billion, getting a product approved is now estimated to cost more than $5 billion, according to a recent analysis by Forbes. If you decide to entrust management of your clinical trial to a contract research organization (CRO), what criteria should you look for in a partner to ensure the most reliable results with the greatest efficiencies at the most affordable price? 

Seed Culture Expansion Process: Reduce Time And Maximize Utilization

This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.

Six Ways To Optimize Your Quality Management System And Ensure FDA And ISO Compliance

How much does quality cost? Most companies would be hard-pressed to translate “quality” into dollars and cents. What they realize, however, is that a lack of quality could cost millions of dollars in rework, scrap, recall, or even liability lawsuits.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Building An Effective GMP Training System: A Risk-Based Approach September 21 - 21, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
3rd Annual Lay Summaries Summit September 24 - 25, 2018
Philadelphia, PA)
PAP Legal Update September 25 - 26, 2018
Arlington, VA)
Finance & Accounting for Bioscience Companies September 25 - 26, 2018
Boston, MA)
4th Annual Bio/Pharmaceutical Product Launch Summit September 25 - 26, 2018
Cambridge, MA)
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